EXTRACTABLE & LEACHABLE
What is Extractable and Leachable Testing?
Extractable and leachable (E&L) testing quantifies the risks associated with finished pharmaceutical product containers, bioprocess manufacturing systems, and medical devices. Extractable and leachables studies are designed to be optimized and customized for the pharmaceutical container or closure under investigation, such as materials and their compatibility with extraction solvents, type of container, type of contact between the container and the medicinal product, storage conditions, specific administration or reconstitution procedures, type of medicinal product, route of administration, dosing regimen, and associated threshold requirements. Identification and quantification of potentially harmful leachable impurities is critical as these could migrate from pharmaceutical container closure systems to contaminate a pharmaceutical product and so pose a risk to a patient’s health and cause significant quality issues.
Our team at VitelyBio is specialized in analytical assessment for Extractable and Leachables & can identify potential sources of risk through strategic screening studies.
Our experts can provide consultative support at every stage of the Extractable and Leachables process, from understanding Extractable and Leachables regulatory requirements to deciding on a suitable test strategy to decoding the results.
How is E&L Testing Conducted?
Sample Preparation
Samples of the product and its packaging are prepared under controlled conditions.
Extraction
The samples are subjected to various solvents and conditions to extract potential Leachables.
Analytical Testing
Advanced analytical techniques such as GC-MS (Gas Chromatography-Mass Spectrometry) and LC-MS (Liquid Chromatography-Mass Spectrometry) are used to identify and quantify the extractables and Leachables.
Data Analysis
The data is meticulously analyzed to determine the presence and concentration of any harmful substances.
Reporting
A comprehensive report is generated, detailing the findings and providing recommendations for any necessary actions.
Why Choose VitelyBio for E&L Testing?
State-of-the-Art Technology
We utilize the latest analytical instruments and methodologies to provide precise and comprehensive testing services.
Regulatory Compliance
Our testing protocols are fully compliant with global regulatory standards, ensuring your products meet all necessary safety requirements.
Fast Turnaround:
Understanding the importance of time in the pharmaceutical industry, we ensure quick and efficient testing processes without compromising on quality.
Expertise and Experience
VitelyBio boasts a team of seasoned scientists with extensive experience in E&L testing, ensuring accurate and reliable results.
Customized Solutions
We offer tailored testing solutions to meet the specific needs of your product, providing you with the most relevant and actionable insights.